Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Arepanrix
Auth. number : EU/1/10/624
Active substance : Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BB - Influenza vaccines
Chemical substance: J07BB02 - influenza, purified antigen
(See WHO ATC Index)
Indication: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1). Pandemic influenza vaccine should be used in accordance with Official Guidance.
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/03/2010 Centralised - Authorisation EMEA/H/C/1201 (2010)2037 of 23/03/2010
16/08/2010 Centralised - Variation EMEA/H/C/1201/IB/5/G
24/11/2010 Centralised - Variation EMEA/H/C/1201/IA/1/G
06/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1201/IB/7
15/12/2010 Centralised - Withdrawal (2010)9294 of 13/12/2010